Matthias Egger Presents EP Solutions at LSI Europe '23

Transcription

Matthias Egger  0:05  
Pre CRT planning to improve CRT outcomes. The CRT stands for cardio resynchronization therapy. It's a device based therapy that's used for heart failure patients that have electric conduction disorder. CRT isn't new. In fact, it's been around for about 20 years. And yet it still fails in over 30% of cases. And this is precisely the issue that we'll be addressing with developing a noninvasive planning step for CRT that will boost the success rate of this life saving therapy. So in CRT electrode leads are inserted through the veins and attached to the heart ventricles. And the the position, the precise position of the electrode lead on the left ventricle of the heart is critical for the successful outcome of the therapy. The challenge is the the optimal position is patient dependent. It's specific to each individual patient. So for any given patient, the physicians do not know where that optimal position is, they'll go in blind, they'll be lucky in 70% of cases, but they will also be unlucky in the other 30. And the costs of non response of this 30 plus percent is massive is of course financial, clinical, it's personal for the patient reputational for the health care provider. And as a consequence, CRT a therapy, that for many of these patients should have a heart transplant is pretty much the last resort. This therapy isn't used nearly as often as it should. What the clinicians really need, they need to remove that blindfold the clinicians need to know and to see where to put the intellectual lead for the therapy to work, and how to get there through which veins they access to get to that point. So how can we add EP solutions address these unlucky 30 We introduce a non invasive planning step without device days ahead of the procedure. Our plan shows the other physician where the target location is in what the best venous access route is ahead of time. Now the physician knows where to go and how to get there, we take luck out of the equation and replace it with personalized data driven guidance. So what have we done so far we've we've built and put on the market, a generation one product, we've CE marked it, we put it on the market to gain clinical evidence across several hospitals in Europe. We've also built up an operation that embraces quality and operates according to the standards and regulations of our industry, including post market clinical follow up procedures. We've protected our IP with a strong portfolio of patents. We've published many papers, some more clinical, some others more technical, and we get a lot of traction from key opinion leaders, most of them, clinicians themselves who feel firsthand that that unmet need and are eager to contribute to a solution. They're also eager to participate in our clinical studies. CRT device vendors are paying attention to what we're doing because improving CRT will impact their device business favorably. Most importantly, most importantly, there we go. We've demonstrated in a multi site study on 111 patients across several sites in Europe, patients who had received prior CRT therapy according to normal standard of care, that our technology works in this context. We verified that those patients were the electrode happened to have been implanted close to the position that we later identified as being the optimal one. Those patients had indeed responded as expected. Those are the the left ones on top left quadrant of the graph. Conversely, the ones that's where the electrode was implanted too far from that optimal location had indeed not responded again, as expected the black ones in the bottom right. So with sensitivity, specificity, specificity values of our tests around 90%. We've taken this fundamental risk out of the project with direct sub project we know our technology works for CRT. We've presented our results at several congresses this year. And cherry on the cake. Our Europese paper was cited in the latest edition of the guidelines of the American Heart Rhythm system. it within an introductory statement to a section it's one sentence, but we believe it's a sentence that will change the way CRT will be administered in future. So where do we go from here, we plan to execute three work packages over the next three years in parallel, first pivotal study randomized control that will link our planning CEP with improved clinical outcomes of the CRT therapy. We've got 14 sites all across Europe ready to go. In fact, the the study has been approved already by the ethics Commission's in the Netherlands or the countries are following. And we are about to enroll the first few of 370 patients from that study. Second development of a generation two product with improved usability and economics for easy foolproof use in a busy routine clinical environment, easy to use a large degree of automation. And a third, our market access activities are completing the MDR transition like everyone else in Europe and going the 510K path with the FDA in America. So this is the scope of the financing round that we preparing for next financing round. That will take the company to a level of maturity level, which we believe will be a good moment for an exit. We also believe that we can shape the market. To some extent the baseline are the existing CRT procedures, both pre procedural planning as I described earlier, but also post procedural optimization during follow up. So that's one. But as improve NCLT gets better. As the outcomes improve, the physicians gain better confidence in it, that will give more and more patients the opportunity to be cured to benefit from this therapy. So it's really driven by better outcomes. And there's in an indirect component to the market as well for a CRT device vendor that would bundle our planning tool with their devices, they would be able to claim better outcomes and improve their market share in the device market as well. We are now starting to prepare the next financing round in q2 of next year. And we opening the capital to new investors up to about 9 million euros that will come on top of the contribution of our existing investors for an overall total of about 14 to 15 million euro. So these three milestones that are described earlier the pivotal study the generation two product and the the the market access in both Europe and America will take the company to significant inflection point in its value. So this is us, we're based in in western Switzerland. Margin and I are here and we'll be happy to answer all the questions you have during these two days. Thank you very much